Lipid Nanoparticle Process Development Scientist

The candidate will have a highly visible and integral role towards the process development, scale-up, and manufacturing of Gene Therapy LNPs. The ideal candidate will have experience with lipid nanoparticle formulation, various mixing equipment, TFF system, characterization tools and understanding/knowledge of process parameters. In this highly collaborative and cross-functional role, you will help develop/optimize the client process and improve process understanding for multiple programs at various stages of non-clinical development. Job Responsibilities Support scale-up development and optimization of LNP drug product formulation processes and storage form development for gene therapies. Provide formulation support for non-GLP large animal studies. Work with cross-functional teams to support process transfer, scale-up, and resolving process troubleshooting. Formulate and characterize LNPs for preclinical studies internal and external to support consistency and high-quality readout across batches and stability evaluations. Maintain records of all relevant data in the electronic laboratory notebook system, hard cover recording (batch record) and present findings to client project teams. Contribute SOP, batch records, report, campaign summary reports, etc. Other duties as assigned. Minimum Qualifications Master’s degree in chemistry, chemical engineering, biomedical engineering, or related fields with 2+ years of relevant industrial working experience preferred. Alternatively, a bachelor’s degree in chemistry, chemical engineering, biomedical engineering, or related fields with 4+ years of recent relevant industrial working experience. Experience in LNP formulation (NanoAssemblr) and nanoparticle characterization. Understanding engineering of process development, scale-up, manufacturing, and tech transfer. Experience with analytical methods (DLS, UV/VIS, Osmo, pH, etc.) for LNP characterization. Experience with large-scale LNP formulation (T-mixing, IJM) and TFF processes. Authorization to work in the United States indefinitely without restriction or sponsorship.

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